When used as a cervical intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

When used as a lumbar intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.

When used as vertebral body replacement devices the Aleutian implants are indicated for use in the thoracolumbar spine (TI to LS) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

For all the above indications the Aleutian implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

Device Description

The Aleutian IBF System consists of a hollow tube or horseshoe-shaped structures manufactured from Medical Grade PEEK (Polyetheretherketone). The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.

Materials: The devices are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTIMA® LTI (Invibio™) per ISO 10993-1 USP Class VI and ASTM F2026. Tantalum beads /rods to be Grade UNS R05200, UNS R05400 according to ASTM F560.

Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical and lumbar segments of the spine.

AI/ML Overview

This 510(k) summary describes a spinal implant. The criteria and study described within are for establishing substantial equivalence for medical devices, not for an AI/ML device. Therefore, much of the requested information regarding AI/ML device performance and testing is not applicable.

Here's the information that can be extracted from the provided text:

Acceptance Criteria and Device Performance for Aleutian IBF System

Acceptance Criteria Category	Description	Device Performance / Proof of Equivalence
Material Composition	Manufactured from Medical Grade PEEK (Polyetheretherketone) OPTIMA® LTI (Invibio™) per ISO 10993-1 USP Class VI and ASTM F2026. Tantalum beads/rods to be Grade UNS R05200, UNS R05400 according to ASTM F560.	The Aleutian IBF System components are made of the same materials as components previously cleared in the Aleutian IBF System 510(k)'s K082698 and K101302 and to the DePuy AcroMed Bengal (K081917). Implied compliance with the stated material standards.
Dimensions & Configuration	Devices are available in a variety of different sizes and heights to match patient anatomy. Ends have machined teeth to engage vertebral body end plates.	The Aleutian IBF System components have similar dimensions and configurations as components previously cleared in the Aleutian IBF System 510(k)'s K082698 and K101302 and to the DePuy AcroMed Bengal (K081917).
Biomechanical Performance	Functions as an intervertebral body fusion device to provide support and stabilization. Designed to restore biomechanical integrity of the spinal column.	Finite element analysis was performed to demonstrate that the components added to the Aleutian IBF System in this 510(k) submission would not result in a new worst-case device under both compressive and torsional loading when testing per ASTM F2077. This demonstrates equivalent biomechanical performance.

Regarding AI/ML Specific Questions:

This document is a 510(k) summary for a physical medical device (spinal implant), not an AI/ML device. Therefore, the following AI/ML-specific questions are not applicable (N/A) based on the provided text:

Sample size used for the test set and the data provenance: N/A (No AI/ML test set mentioned)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A
Adjudication method for the test set: N/A
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A
The sample size for the training set: N/A
How the ground truth for the training set was established: N/A

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a substantial equivalence comparison to previously cleared predicate devices (K082698, K101302, and DePuy AcroMed Bengal K081917).

Methods:
- Material Comparison: Documentation was provided demonstrating that the subject Aleutian IBF System components are made of the same materials as the predicate devices.
- Dimensional/Configuration Comparison: The new components have similar dimensions and configurations to the predicate devices.
- Biomechanical Analysis: Finite element analysis was performed.
Purpose of Finite Element Analysis: To demonstrate that the components added in this 510(k) submission would not result in a new worst-case device under both compressive and torsional loading when testing per ASTM F2077, indicating equivalent biomechanical safety and performance.

In essence, the study demonstrated that the new Aleutian IBF System is substantially equivalent to already marketed devices through material, dimensional, and biomechanical (finite element analysis) comparisons, rather than a clinical study with acceptance criteria often associated with novel technologies or AI/ML solutions.

Summary

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MAR - 7 2011

510(k) Summary Aleutian IBF System K2M, Inc.

This safety and effectiveness summary for the Aleutian IBF System is provided as required per Section 513((i)(i) of the Food, Drug and Cosmetic Act.

Submitter :

K2M, Inc. 751 Miller Drive SE Suite Fl Leesburg, VA 20175

Date Prepared: May 7, 2010 Contact Person : Nancy Giezen K2M, Inc. 751 Miller Drive SE, Suite Fl Leesburg, VA 20175 Telephone: 703-777-3155

Aleutian IBF System 2. Tradename: Intervertebral Body Fusion Device Common Name: Intervertebral Fusion Device with Bone Graft, lumbar (Product Code: MAX) Classification Name: Intervertebral Fusion Device with Bone Graft, cervical (Product Code: ODP) Spinal Vertebral Body Replacement Device (Product Code: MQP) Regulation Number: 888.3080. 888.3060

3. Description of the device:

Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical and lumbar segments of the spine.

4. Intended Use:

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The Aleutian implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

5. Predicate or legally marketed devices which are substantially equivalent:

Documentation was provided which demonstrated that the subject Aleutian IBF System components are made of the same materials with similar dimensions and configurations as components previously cleared in the Aleutian IBF System 510(k)'s K082698 and K101302 and to the DePuy AcroMed Bengal (K081917).

6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:

Finite element analysis was performed to demonstrate that the components added to the Aleutian IBF System in this 510(k) submission would not result in a new worst-case device under both compressive and torsional loading when testing per ASTM F2077.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three abstract shapes resembling birds in flight, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

K2M, Inc. % Ms. Nancy Giezen 751 Miller Drive SE, Suite F1 Leesburg, Virginia 20175

MAR - 7 201

Re: K103169

Trade/Device Name: Aleutian IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX, MQP Dated: February 10, 2011 Received: February 11, 2011

Dear Ms. Giezen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Ms. Nancy Giezen

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Aliz B. nh
for

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): KIO3169

Aleutian IBF System Device Name :

Indications For Use :

When used as vertebral body replacement devices the Aleutian implants are indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

Prescription use X

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Over-the-counter use ( PER 21 CFR 801.109)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation ( ODE )

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K103169 510(k) Number_

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.